Loading clinical trials...

Feasibility of Self-treatment of Painful Diabetic Neuropathy Using Electrical Vasomotor Nerve Stimulation | Clinical Trials | Clareo Health

COMPLETEDNA

Feasibility of Self-treatment of Painful Diabetic Neuropathy Using Electrical Vasomotor Nerve Stimulation

NCT06524284•Neurecon BV

View on ClinicalTrials.gov

Summary

Electrical stimulation with EVNS (Electrical Vasomotor Neuro Stimulation), a methodology used by a specific group of neurostimulators known under various names, has proven its benefit in Painful Diabetic Neuropathy (PDN). However, due to the impaired mobility from Diabetic Neuropathy, a part of subjects did not finish the 10 days treatment in the outpatient clinic. Another part of the target group decided not to participate at all for the same reason. The current study investigates the feasibility, safety and performance of a newly developed EVNS device, called Releaf™, optimised for HOME treatment,

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Painful Diabetic Neuropathy (DN4 positive) and insufficiently treated with any combination of 2 of the following drugs: Duloxetine (Cymbalta), venlafaxine (Efexor), ami- or nortriptyline, gabapentine, pregabaline (Lyrica) or the use of carbamazepine or capsaïcine (Qutenza).
•Both feet are present
•Able and willing to complete the treatments in 10 days in a row and completion of questionnaires.
•Being in a mental and physical state to perform home self-treatment with Releaf™ for 10 consecutive days, if necessary with adequate assistance of caregiver.
•Being in a mental and physical state to understand and complete the informed consent form as well as the research questionnaires.

Exclusion Criteria

•In case of other evident causes for painful neuropathy,
•Currently participating in another interventional investigational study
•Significant peripheral arterial disease,
•Active foot ulceration or other skin conditions that prevent the application of electrodes on the skin
•Current alcohol or other substance abuse (use of alcohol over the recommended limits of less than 21 units of alcohol per week in men and 14 units in women, Trimbos Intitute),
•Epilepsy,
•Pregnancy,
•Presence of a medical device based on electrical stimulation, cardiac pacemaker and/or implantable cardioverter defibrillator or any other active implant
•Allergy to electrode contact area or to the adhesive substance of the electrode.

Locations (1)

Neurecon

Vught, Netherlands

Key Dates

Start Date

July 22, 2024

Primary Completion Date

March 4, 2025

Completion Date

March 30, 2025

Last Updated

December 9, 2025

Enrollment

ACTUAL participants

Conditions

Painful Diabetic Neuropathy

Interventions

Releaf

DEVICE

Safety, Tolerability & Pharmacokinetics Study of CNTX-6016 in Healthy Subjects and Subjects With PDN

NCT04857957

Painful Diabetic Neuropathy

View study

COMPLETEDNA

Axon Therapy and Conventional Medical Management for Painful Diabetic Neuropathy Compared to Sham and Conventional Medical Management

NCT05620225

NeuralgiaNeuropathic Pain+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 9, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Feasibility of Self-treatment of Painful Diabetic Neuropathy Using Electrical Vasomotor Nerve Stimulation

Inclusion Criteria

Exclusion Criteria

Safety, Tolerability & Pharmacokinetics Study of CNTX-6016 in Healthy Subjects and Subjects With PDN

Axon Therapy and Conventional Medical Management for Painful Diabetic Neuropathy Compared to Sham and Conventional Medical Management

Diabetic Small Fiber Neuropathy: Clinical, Electrophysiological and Neurosonographic Study

A Trial to Assess the Efficacy and Safety of 400mg/Day Lacosamide in Subjects With Painful Diabetic Neuropathy

A 12-Week Study of Topical Pirenzepine or Placebo in Type 2 Diabetic Patients (T2DM) With Painful Peripheral Neuropathy

Graded Exposure in Patients With Painful Diabetic Neuropathy